Regulatory Affairs Specialist (Sports Medicine)

Regulatory Affairs Specialist (Sports Medicine)

Smith & Nephew

United Kingdom

What will you be doing?

You will be instrumental in ensuring that our products meet all regulatory requirements for global markets. You will develop and implement regulatory strategies, ensuring timely product launches and compliance with all relevant regulations.

• Preparing global regulatory submissions, including 510(k), PMA, MDR Technical Files, and Annual Reports, covering new and modified devices.
• Working closely with our project teams to develop regulatory strategies, testing requirements, and documentation to ensure timely and approved regulatory submissions.
• Keep up-to-date with current and upcoming regulations, standards, and requirements for facility registration, device listing, import/export, and UDI.
• Managing databases to ensure only approved products are sold and supervise UDI systems.
• Maintaining regulatory systems for tracking submissions, impact assessments, and metrics.
• Review and approve engineering and manufacturing changes to maintain compliance.
• Developing instructions for use (IFU) content with support from core functional leads and review IFUs, Surgical Techniques, and promotional materials to ensure compliance.
• Supporting International Registrations for the product portfolio for all regions.
• Supporting internal and external audits when necessary.

What will you need to be successful?

We're looking for someone with a Bachelor's degree or equivalent work experience, preferably in a scientific or technical field, plus 2-3+ years experience in Regulatory Affairs. You should be experienced in US & EU MDR regulatory requirements.

The ideal candidate for this role is driven and a go-getter, capable of taking information, synthesising it, and putting it into practice effectively. You'll be guided by acting ethically, as this notion sits at the heart of our team. This role ensures that products provided to patients are safe and effective, exercising regulations with a foundation of ethics and care. You'll be a creative problem solver with strong critical thinking skills, adept at finding solutions where not everything is black and white.

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